On December 5, 2019 Mogrify Ltd (Mogrify), a UK company aiming to transform the development of cell therapies, reported that it received MSD’s Innovation Award at the 15th Annual Scrip Awards, and the Lifetime Achievement Award was presented to Dr. Jane Osbourn, OBE, Chair at Mogrify (Press release, Mogrify, DEC 5, 2019, View Source [SID1234553997]). The Innovation Award recognizes the significant potential the Company’s direct cellular conversion technology has to disrupt the future development of new medicines. Dr. Osbourn received the Lifetime Achievement Award in recognition of her outstanding contribution to the biotech industry throughout her career.

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Mogrify has developed a proprietary direct cellular conversion technology, which makes it possible to transform any human cell type into any other, without going through a pluripotent stem cell- or progenitor cell-state. The Company is using this platform to produce cell types with unrivaled safety, efficacy and scalable manufacturing profiles that can be used to develop novel cell therapies addressing musculoskeletal, auto-immune, cancer immunotherapy, ocular and respiratory diseases.

Dr. Osbourn is a scientific leader in the field of antibody engineering with more than 30 years of experience in biologics discovery and development. During this time she has been Vice President for Research and Development and Site Leader at MedImmune (AstraZeneca), formerly Cambridge Antibody Technology (CAT), Chair of the Board of Directors of the BioIndustry Association, a Director of Babraham Bioscience Technologies, and a Director of Cambridge Enterprise. She has made significant contributions to the discovery and development of phage display technology, eight marketed drugs (including HUMIRA and BENLYSTA) and over 40 clinical candidates. Dr. Osbourn holds a doctorate from the John Innes Institute in Norwich, UK and a first-class degree in natural sciences from the University of Cambridge, and was awarded an OBE for services to drug discovery, development and biotechnology.

The Scrip Awards seek to applaud the role that the pharmaceutical, biotech and other allied industries play in improving healthcare. Its trophies span a range of industry activities, from new drug launches and clinical trials, to innovative deals, outsourcing and fundraising. This year’s new category, MSD’s Innovation Award, acknowledges and celebrates the outstanding scientific or technological breakthroughs that have the potential to be transformative in the discovery or development of new medicines. Scrip’s Lifetime Achievement Award is presented to individuals who have had a distinguished career in the biotech or pharmaceutical arena, primarily within industry with a consistent history of exceptional service, throughout their career.

Dr. Darrin M. Disley, OBE, CEO, Mogrify, said: "Our systematic approach to the discovery of novel cell conversions has the potential to transform cell therapy. Mogrify’s technology opens up the opportunity to develop and scale up any autologous and allogeneic cell therapies, as well as create a new class of therapies: in vivo reprograming and could therefore have a significant impact on the treatment of degenerative conditions and cancers. We are proud to have our innovative platform and pioneering approach recognized by the judges.

Dr. Osbourn has contributed significantly to the industry throughout her impressive career and is globally renowned for her expertise in biologics discovery and development. She is an inspirational leader and we look forward to celebrating her exceptional achievements."

Dr. Jane Osbourn, OBE, Chair, Mogrify, said "I am honored to have received the Lifetime Achievement Award. Throughout my career I have been fortunate to have worked with many pioneering scientists, who have helped us achieve success in biologics discovery and development. Working together in a diverse team is vital if we are to build great culture and drive innovation. I would like to thank all the extraordinary people who have supported me and I hope to continue to foster many more successful collaborations."

Prof. Jose Polo, CMO (Co-founder) and Prof. Julian Gough, CSO (Co-founder) were presented with the Innovation Award at the prestigious ceremony, which took place in at the London Hilton on Park Lane in Mayfair on 4 December.

On December 5, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the European Medicines Agency ("EMA") has agreed to the Company’s proposed Pediatric Investigation Plan ("PIP") for omburtamab (Press release, Y-mAbs Therapeutics, DEC 5, 2019, View Source [SID1234551989]). The decision was made on the basis of a positive opinion from EMA’s Pediatric Committee ("PDCO"). Omburtamab is being developed by Y-mAbs for the treatment of CNS/leptomeningeal metastases from neuroblastoma which is the indication targeted by the PIP, as well as a number of additional cancer indications.

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As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for filing a Marketing Authorization Application ("MAA") for any new medicinal product in Europe.

"We are pleased to announce this important regulatory milestone. The approval of the PIP provides Y-mAbs with a clear path for registration of omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma. We look forward to continuing to work with EMA and PDCO to bring this important therapy to the European market as soon as possible," said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer further notes, "We are preparing the European submission of the marketing authorization application for omburtamab, and plan for submission in the second half of 2020. This is a vital step forward in our efforts of bringing omburtamab to the market in Europe, and it demonstrates the close and constructive interactions established with the regulatory authorities in Europe.

Researchers at Memorial Sloan Kettering ("MSK") developed the therapeutic product referenced in this statement, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product and in Y-mAbs.

On December 5, 2019 ARTIDIS reported a privately held healthtech company, announced today the successful closure of a CHF 8.8 million seed financing in two rounds, securing early clinical validation and the next development phase towards market entry in 2021 (Press release, ARTIDIS, DEC 5, 2019, View Source;raising-chf-8-8-million-in-seed-financing-300969365.html [SID1234551988]). The funding will be used to advance the company’s healthtech platform into a large multi-centre clinical study together with the University Hospital Tuebingen (Germany), University Hospital Barcelona (Spain), and Texas Medical Center (Houston, US). The study aims to further validate the value of ARTIDIS in diagnosing breast and lung cancer, as well as for personalizing and optimizing cancer treatment. The results will support the regulatory submissions to the FDA and the European Notified Body to gain approval for the ARTIDIS medical device and data platform. This is one of the major prerequisites for ARTIDIS to enter the diagnostic market world-wide in 2021 in order to improve the standard of care for cancer patients.

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Dr. Marija Plodinec, CEO of ARTIDIS commented: "The closure of this financing round and the successful recruitment of 545 patients in our first clinical study at the University Hospital Basel this year is a huge success. We are thankful for the support and trust of all our shareholders – together, we are opening a new chapter towards personalizing the patient journey."

The round was supported by family offices and private individuals from Switzerland and the EU, including BERNINA Bioinvest, Zurich and SMD MedicalTrade AG, Taegerwilen.

"We are extremely happy for the opportunity to invest in this promising company and support the great team of ARTIDIS on their mission to deliver fast diagnosis and personalized treatment to cancer patients," stated Philipp Looser from SMD Medical Trade AG.

The management of BERNINA BioInvest commented: "ARTIDIS brings the future of cancer diagnostics and treatment to the patients and clinicians. We support ARTIDIS because their approach will significantly optimize the diagnostics workflow and has the potential to revolutionize the way treatment decision-making is done, improving not only the personal patient journey but benefiting the whole healthcare ecosystem. We are confident that Marija Plodinec and her team have the expertise, the passion, and the drive needed to realize this vision."

Martin Gertsch, Chairman of the Board says: "We are very glad that we could also strengthen our Board of Directors during this year: Owing to their significant industry experience and diverse subject matter expertise, Ms Trudi Haemmerli, Board Member Innosuisse, and Dr. Reinhard Ambros, former Global Head of Novartis Venture Fund, were both elected as Board of Directors this year."

On December 5, 2019 Epic Sciences, Inc. reported the presentation of new data demonstrating the feasibility of using its proprietary technology for the detection and characterization of rare cells to guide the treatment of breast cancer (Press release, Epic Sciences, DEC 5, 2019, View Source [SID1234551987]). The data to be presented show the use of Epic Sciences’ liquid biopsy test to profile circulating tumor cells (CTCs) based on morphological features, protein marker expression and genomic alterations. Epic Sciences will present the data at the 2019 San Antonio Breast Cancer Symposium held on December 10 – 14, in San Antonio, Texas.

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Epic’s platform detects and characterizes all circulating tumor cells in a blood sample in an effort to predict their response or resistance to drug therapies. Epic Sciences’ first application of this technology was successfully developed as a test for patients with metastatic castration-resistant prostate cancer and is currently marketed as the Oncotype DX AR-V7 Nucleus Detect test. The company and its research partners are utilizing its liquid biopsy solution to identify and analyze CTCs to guide treatment decisions in breast cancer.

"We are now applying our proven expertise in prostate cancer to breast cancer, a disease shown to have biological similarities. The ability to identify CTCs with great precision and provide multi-dimensional characterization may have significant impact in guiding treatment decisions in breast cancer," said Rick Wenstrup, MD, chief medical officer at Epic Sciences. "We’re excited about this promising data and our ability to identify cancer cell clones and subtypes. We look forward to sharing additional findings in the future."

Following are the details for the two poster sessions:
Title: Phenotypic profiling of circulating tumor cells (CTCs) in patients with metastatic breast cancer reveals clinically-relevant heterogeneity in CTC morphology and marker expression.
First Author: Tiziano Pramparo, PhD, Senior Biomarker Scientist
Date and Time: Friday, December 13, 2019, 7:00 am – 9:00 am
Poster Session: 4
Abstract: 874
Poster Board: P4-01-09

Title: Computer Vision and Machine Learning Allow for the Prediction of Genomic Instability Using Circulating Tumor Cell Morphology in Triple Negative Breast Cancer Patients
First Author: Adam Jendrisak, MBA, Data Scientist
Date and Time: Friday, December 13, 2019, 7:00 am – 9:00 am
Poster Session: 4
Abstract: 878
Poster Board: P4-01-03

On December 5, 2019 Thermo Fisher Scientific reported Clinical researchers who take a traditional sequential approach to analyze myeloid malignancies, a highly heterogeneous group of disorders, face a major hurdle: a laborious and time-consuming workflow (Press release, Thermo Fisher Scientific, DEC 5, 2019, View Source [SID1234551986]). To simplify and accelerate the genomic profiling process, Thermo Fisher Scientific announced that the Ion Torrent Oncomine Myeloid Research Assay* will be available in 2020 to run on the newly introduced Ion Torrent Genexus System*, the first fully integrated next-generation sequencing (NGS) platform featuring an automated workflow that delivers results economically in a single day with minimal user intervention and tissue sample input.

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"For the past two years we have been using Thermo Fisher’s NGS technology to analyze myeloid samples, and the Oncomine Myeloid Research Assay provides a comprehensive assessment to identify relevant variants in a single step," said Bekim Sadikovic, Ph.D., associate professor of pathology and laboratory medicine at Western University and division head of the Molecular Diagnostics Division in the Department of Pathology and Laboratory Medicine at London Health Sciences Centre. "Making this assay available on a platform that can deliver results in a single day would provide labs with the answers they need for key mutations such as FLT3-ITDs, TP53, CEBPA, NPM1, KIT, PML-RARA and other biomarkers."

Thermo Fisher introduced the Genexus System* in November, and will demonstrate the platform at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (booth #140) being held in Orlando, Fla. from December 7-10.

"The Genexus System holds promise to redefine the genomic profiling paradigm," said Andy Felton, vice president of product management for clinical next-generation sequencing and oncology at Thermo Fisher. "We have heard significant interest from our customers in the potential to run our Oncomine Myeloid Research Assay on the new platform. Delivering on that need will mean that hematology and oncology labs can quickly get the results they need."

Expanded Portfolio Addresses Full Range of Hematology Applications

Thermo Fisher also announced an expanded portfolio of NGS-based hematology-oncology research assays that make it easier to assess lymphoid malignancies. The new Oncomine BCR IGH-LR Assay provides accurate clonality assessment and somatic hypermutation in chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL). The Oncomine BCR IGH-SR Assay measures residual disease (MRD) in lymphoid malignancies with higher sensitivity and lower limit of detection (LOD) than traditional methods.

Thermo Fisher’s hematology portfolio includes the Oncomine Childhood Cancer Research Assay*. All of Thermo Fisher’s hematology and oncology assays are compatible with the Ion GeneStudio S5 System*, providing an end-to-end, streamlined NGS workflow for consolidated biomarker testing. The system also includes Thermo Fisher’s bioinformatics software to deliver more comprehensive information and easier interpretation of NGS biomarker testing.

For more information on Thermo Fisher’s portfolio of hematology and oncology assays, please visit www.oncomine.com/heme or visit the company’s booth (#140) at ASH (Free ASH Whitepaper) for a live demonstration of the Genexus System.